LEVOFLOXACIN STADA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levofloxacino Stada 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Levofloxacino Stada and what is it used for
2. What you need to know before you take Levofloxacino Stada
3. How to take Levofloxacino Stada
4. Possible side effects
5. Storage of Levofloxacino Stada
6. Contents of the pack and other information

1. What is Levofloxacino Stada and what is it used for

Levofloxacino Stada contains the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a quinolone antibiotic and works by killing the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or the common cold.

It is important that you follow the instructions regarding dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Levofloxacin can be used to treat infections in:

• the paranasal sinuses
• the lungs, in people with long-term respiratory problems or pneumonia
• the urinary tract, including the kidneys or bladder
• the prostate, when the infection is persistent
• the skin and under the skin, including muscles. This is sometimes referred to as "soft tissue"

In some special situations, levofloxacin can be used to reduce the possibility of acquiring a lung infection called anthrax or worsening of such disease after being exposed to the bacteria that causes anthrax.

2. What you need to know before you take Levofloxacino Stada

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacin, to other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6)
• Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue
• You have or have had epilepsy
• You have ever had tendon problems, such as tendinitis, related to the use of quinolone medicines. The tendon is the tissue that connects your muscle to your skeleton
• You are a child or adolescent in the growth phase
• You are pregnant, might be pregnant, or think you might be pregnant
• You are breastfeeding

Do not take this medicine if any of the above cases apply to you. If in doubt, consult your doctor or pharmacist before taking levofloxacin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take your medicine if:

• You are 60 years old or older
• You are using corticosteroids, sometimes called steroids (see section "Other medicines and Levofloxacino Stada")
• You have received an organ transplant
• You have had a seizure (convulsions)
• You have had brain damage due to a stroke or other brain injury
• You have kidney problems
• You have what is known as "glucose-6-phosphate dehydrogenase deficiency", as you may be prone to having serious blood problems when taking this medicine
• You have had mental health problems
• You have ever had heart problems: caution should be exercised when using this type of medicine, if you were born with, or have a family history of prolongation of the QT interval (seen on the electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an elderly person or are taking other medicines that may cause abnormal changes in the ECG (see section "Other medicines and Levofloxacino Stada")
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis
• You have peripheral nerve disorder (peripheral neuropathy)
• If you have been diagnosed with an aneurysm or a "bulge" of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm)
• If you have had a previous episode of aortic dissection (tear in the aortic wall)
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves)
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection))
• You have developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacin

Tell your doctor or pharmacist before taking levofloxacin if you are not sure if any of the above cases apply to you.

Do not take antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacin, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

During treatment with this medicine

• If you feel a sudden and severe pain in the abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go immediately to the emergency room. The risk may increase if you are receiving systemic corticosteroid treatment
• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately
• If you start experiencing sudden and involuntary jerks, muscle spasms, or muscle contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacin and initiate appropriate treatment
• If you have nausea, general discomfort, have intense discomfort or continuous pain, or worsening pain in the stomach area, or vomiting - consult a doctor immediately, as this could be a sign of pancreatitis (acute pancreatitis)
• If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be decreased - consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. In case of abnormal blood counts, your doctor may need to interrupt treatment

Rarely, pain and swelling in the joints and inflammation or rupture of the tendons can occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with levofloxacin. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.

Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

Severe skin reactions

Severe skin reactions have been reported, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) with the use of levofloxacin.

• SJS/TEN can initially appear on the trunk as reddish targets or circular patches, often with blisters in the center. They can also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening complications.
• DRESS is initially manifested with flu-like symptoms and a rash on the face, then a more widespread rash with elevated body temperature, elevated liver enzyme levels observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

If you develop a severe rash or any of these skin symptoms, stop taking levofloxacin and contact your doctor or seek medical attention immediately.

If you experience any of these side effects after taking levofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic of another class.

Other medicines and Levofloxacino Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because levofloxacin can affect the way other medicines work. Also, some medicines can affect the way levofloxacin works.

In particular, tell your doctor if you are taking any of the following medicines, as this increases the possibility of experiencing side effects when taking them with levofloxacin:

• Corticosteroids, sometimes called steroids - used for inflammation. You may have a higher chance of experiencing tendon inflammation and/or rupture
• Warfarin - used to make the blood more liquid. You may have a higher chance of experiencing bleeding. Your doctor may need to perform periodic blood tests to check if your blood is clotting correctly
• Theophylline - used for respiratory problems. You may have a higher chance of experiencing a seizure (convulsions) if you take it with levofloxacin
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have a higher chance of experiencing a seizure (convulsions) when taking them with levofloxacin
• Cyclosporin - used after organ transplants. You may have a higher chance of experiencing the adverse effects of cyclosporin
• Medicines with a known effect on heart rhythm. This includes medicines used for irregular heart rhythm (anti-arrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin)
• Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special care should be taken when taking these medicines with levofloxacin. If you have kidney problems, your doctor may want to give you a lower dose.

Tell your doctor if any of the above cases apply to you.

Do not take levofloxacinat the same time as the following medicines, as it may affect the way levofloxacin works:

• Iron tablets (for anemia), zinc supplements, antacids that contain aluminum or magnesium (for acidity or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 "If you are already taking iron, zinc supplements, antacids, didanosine, or sucralfate" below.

Determination of opiates in urine

Urine tests may show "false positive" results for the presence of strong painkillers called "opiates" in patients taking levofloxacin. Inform your doctor that you are taking levofloxacin if you have been prescribed a urine test.

Tuberculosis test

This medicine may cause a "false negative" result in some laboratory tests used to detect the bacteria that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

• you are pregnant, might be pregnant, or think you might be pregnant
• you are breastfeeding or plan to breastfeed

Driving and using machines

Some side effects such as dizziness, drowsiness, balance disturbance (vertigo), or visual disturbances may occur. Some of these side effects can affect your ability to concentrate or slow down your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

3. How to Take Levofloxacino Stada

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

How to Take this Medication

• Take this medication by mouth
• Swallow the tablets whole with a little water
• The tablets can be taken during or between meals

Protect Your Skin from Sunlight

Do not expose your skin directly to the sun (even when cloudy) while taking this medication and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, sting, or even blister if you do not take the following precautions:

• Make sure to use high-protection sun creams
• Always wear a hat and clothing that covers your arms and legs
• Avoid ultraviolet (UVA) lamps

If You Are Already Taking Iron Tablets, Zinc Supplements, Antacids, Didanosine, or Sucralfate

• Do not take these medications at the same time as levofloxacino. You should take these medications at least two hours before or two hours after taking levofloxacino.

What Dose Should You Take

• Your doctor will decide what amount of levofloxacino you should take.
• The dose will depend on the type of infection you have and where the infection is located in your body.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medication is too weak or strong, do not change the dose yourself, ask your doctor.

Adults and Elderly Patients

Infection in the paranasal sinuses

• one levofloxacino 500 mg tablet, once a day

Infection in the lungs, in people with long-term respiratory problems

• one levofloxacino 500 mg tablet, once a day

Pneumonia

• one levofloxacino 500 mg tablet, once or twice a day

Infection in the urinary tract, including kidneys or bladder

• half or one levofloxacino 500 mg tablet, once a day

Infection in the prostate

• one levofloxacino 500 mg tablet, once a day

Infection in the skin and under the skin, including muscles

• one levofloxacino 500 mg tablet, once or twice a day

Adults and Elderly Patients with Kidney Problems

Your doctor may give you a lower dose.

Children and Adolescents

This medication should not be given to children or adolescents.

If You Take More Levofloxacino Stada Than You Should

If you accidentally take more tablets than you should, inform your doctor or get immediate medical help. Take the medication with you so the doctor knows what you have taken. You can also call the Toxicology Information Service on 91 562 04 20, stating the medication and the amount ingested.

The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that can cause irregular heartbeats, as well as discomfort (nausea) or stomach burning.

If You Forget to Take Levofloxacino Stada

If you forget to take a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

If You Interrupt Treatment with Levofloxacino Stada

Do not interrupt your treatment with levofloxacino even if you feel better. It is important that you complete the treatment that your doctor has prescribed. If you stop taking them too soon, the infection may come back, your condition may worsen, or the bacteria may become resistant to the medication.

If you have any other questions about the use of the medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them. They are usually mild to moderate and tend to disappear in a short time.

Interrupt Treatment with Levofloxacinoand Contact a Doctor or Go to the Hospital Immediately if You Notice the Following Adverse Effects:

Very Rare(may affect up to 1 in 10,000 people)

• If you have an allergic reaction. The signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue

Interrupt Treatment with Levofloxacinoand Contact a Doctor Immediately if You Notice the Following Serious Adverse Effects, as You May Need Urgent Medical Treatment:

Rare(may affect up to 1 in 1,000 people)

• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem
• Pain and inflammation in the tendons or ligaments, which could lead to rupture. The Achilles tendon is the one most frequently affected
• Epileptic seizures (convulsions)
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams, or nightmares
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH)
• Decreased blood sugar levels (hypoglycemia) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is important for diabetic patients

Very Rare(may affect up to 1 in 10,000 people)

• Burning, tingling, pain, or numbness. These can be signs of what is called "neuropathy"

Frequency Not Known(cannot be estimated from available data)

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms. See also section 2.

• Lack of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems, including liver failure
• Changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
• Nausea, general discomfort, stomach upset, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Consult an eye specialist immediately if your vision deteriorates or you have any other eye problems while taking levofloxacino.

Tell Your Doctor if Any of the Following Adverse Effects Worsen or Last More Than a Few Days:

Frequent(may affect up to 1 in 10 people)

• Sleep problems
• Headache, dizziness
• Discomfort (nausea, vomiting) and diarrhea
• Increased levels of some liver enzymes in the blood

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may require treatment
• Changes in the number of white blood cells in your blood test results (leucopenia, eosinophilia)
• Anxiety (anxiety), confusion, nervousness, drowsiness, tremors, feeling of dizziness (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach disorders, or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence), or constipation
• Itching and skin rash, intense itching, or hives (urticaria), excessive sweating (hyperhidrosis)
• Pain in the joints or muscle pain
• Abnormal values in your blood tests due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• General weakness

Rare(may affect up to 1 in 1,000 people)

• Appearance of bruises and easy bleeding due to a decrease in the number of blood platelets (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Tingling sensation in hands and feet (paresthesia)
• Ear disorders (tinnitus) or vision disorders (blurred vision)
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)

• Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous system)
• Changes in kidney function and occasional kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis
• Fever
• Clearly defined erythematous patches with or without blisters that develop a few hours after administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; usually, they recur in the same area of the skin or mucous membrane after subsequent exposure to levofloxacino.
• Memory impairment

Frequency Not Known(cannot be estimated from available data)

• Decrease in red blood cells in the blood (anemia): this can cause the skin to become pale or yellowish due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia)
• The bone marrow stops producing new blood cells, which can cause fatigue, decreased ability to fight infections, and uncontrolled bleeding (bone marrow failure)
• Fever, sore throat, and persistent general malaise. This can be due to a decrease in the number of white blood cells (agranulocytosis)
• Circulatory collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia). This is important in people with diabetes
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling very excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision, eye inflammation
• Hearing or vision problems
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Allergic pulmonary reactions
• Pancreas inflammation (pancreatitis)
• Liver inflammation (hepatitis)
• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity), darker skin areas (hyperpigmentation)
• Inflammation of the blood vessels that carry blood throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle rupture and destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus)
• Porphyria crisis in patients with porphyria (a very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve failure in patients who have received fluoroquinolones. See also section 2.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Levofloxacino Stada

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Levofloxacino Stada

The active ingredient is levofloxacino. Each tablet contains 500 mg of levofloxacino (as hemihydrate).

The other components (excipients) are:

• Core: crospovidone, hypromellose, microcrystalline cellulose, magnesium stearate, colloidal silica, stearic acid, and talc.
• Coating: titanium dioxide (E-171), hypromellose, macrogol 6000, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the Product and Package Contents

Levofloxacino Stada are film-coated tablets for oral use. The tablets are orange, elongated, biconvex, and scored.

They are available in packages of 1, 7, 14, and 200 (clinical package) tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This leaflet does not contain all the information about your medication. If you have any questions or are unsure about something, consult your doctor or pharmacist.

Date of the Last Revision of this Leaflet:December 2024

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/